Clinical trial · Interventional
Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Relapsed or Refractory Acute Leukemia
Phase I Study of a Pharmacologically Derived Hybrid Bolus-Infusion Schedule of Flavopiridol (NSC 649890, IND 46,211) Given in Timed Sequential Combination With Cytosine Arabinoside (Ara-C) and Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias
NCT00470197CI-TRIAL-00012312completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Drugs used in chemotherapy, such as flavopiridol, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving a new schedule of more than one drug (combination chemotherapy) may kill more cancer cells. This phase I trial is studying the side effects, best dose, and best schedule for flavopiridol when given together with cytarabine and mitoxantrone in treating patients with relapsed or refractory acute leukemia.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Megakaryoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Myeloid Leukemia with Minimal Differentiation | ALIAS | 0.90 |
| Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Monocytic Leukemia (M5b) | Adult Acute Monocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloblastic Leukemia With Maturation (M2) | Adult Acute Myeloid Leukemia with Maturation | ALIAS | 0.90 |
| Adult Acute Myeloblastic Leukemia Without Maturation (M1) | Adult Acute Myeloid Leukemia without Maturation | ALIAS |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive flavopiridol IV over 30 minutes on days 1, 2, and 3. Patients receive cytarabine IV continuously over 72 hours beginning on day 6 and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
- interventionNames
- Drug: alvocidib
- Drug: cytarabine
- Drug: mitoxantrone hydrochloride
- Other: pharmacological study
Primary outcomes (1)
- measure
- Maximum tolerated dose determined by dose-limiting toxicities graded according to NCI-CTC version 3.0
- timeFrame
- Up to 63 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Pathologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia:
* Relapsed \>= 1 time OR refractory disease:
* Patients who fail primary induction therapy or who relapse after achieving complete remission are eligible if they have received =\< 3 prior courses of induction/reinduction therapy
* Relapsed \>= 1 time OR refractory disease
* Patients who fail primary induction therapy or who relapse after achieving complete remission are eligible if they have received =\< 3 prior courses of induction/reinduction therapy
* No active CNS leukemia
* ECOG performance status 0-2
* AST and ALT =\< 5 times upper limit normal (ULN)
* Alkaline phosphatase =\< 5 times ULN
* Bilirubin =\< 2.0 mg/dL
* Creatinine =\< 2.0 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* LVEF \>= 45% by MUGA or ECHO
* No active, uncontrolled infection
* No other life-threatening illness
* No mental deficits and/or psychiatric history that would preclude study compliance
* No active graft-vs-host disease
* Recovered from all prior therapies
* At least 24 hours since prior hydroxyurea, steroids, imatinib mesylate, arsenic trioxide, interferon, or leukapheresis for blast count control
* At least 4 weeks since prior stem cell transplantation (autologous or allogeneic)
* At least 4 days since prior growth factors
* At least 3 weeks since prior chemotherapy, except for non-aplasia producing treatments (e.g., low-dose cyclophosphamide, hydroxyurea, interferon, imatinib mesylate, mercaptopurine, thalidomide, azacitidine, or decitabine)
* No prior flavopiridol
* No other concurrent chemotherapy, radiotherapy, or immunotherapy
* No acute promyelocytic leukemia (M3)
* No hyperleukocytosis with \> 50,000 blasts/mm\^3References
Publications (1)
- DERIVEDKarp JE, Smith BD, Resar LS, Greer JM, Blackford A, Zhao M, Moton-Nelson D, Alino K, Levis MJ, Gore SD, Joseph B, Carraway H, McDevitt MA, Bagain L, Mackey K, Briel J, Doyle LA, Wright JJ, Rudek MA. Phase 1 and pharmacokinetic study of bolus-infusion flavopiridol followed by cytosine arabinoside and mitoxantrone for acute leukemias. Blood. 2011 Mar 24;117(12):3302-10. doi: 10.1182/blood-2010-09-310862. Epub 2011 Jan 14. PMID 21239698